Levetiracetam Versus Standard Antiepileptic Drugs (Carbamazepine and Valproate) Used as Monotherapy in Patients With Newly Diagnosed Epilepsy
A Therapeutic Confirmatory, Open-label, Multi-center, Randomized 2 Parallel Groups, Community-based Trial Studying the Efficacy and Safety of Levetiracetam (1000 to 3000 mg/Day Oral Tablets 250-500 mg b.i.d.) Compared to Sodium Valproate (1000 to 2000 mg/Day Oral ER Tablets 300-500 mg b.i.d.) and Carbamazepine (600 to 1600 mg/Day Oral CR Tablets 200-400 mg b.i.d.) as Monotherapy in Subjects With Newly Diagnosed Epilepsy.
2 other identifiers
interventional
1,701
23 countries
223
Brief Summary
Study N01175 was to compare overall effectiveness (efficacy and safety) of levetiracetam (LEV) versus the 2 older antiepileptic drugs (AEDs), sodium valproate extended release (VPA-ER) and carbamazepine controlled release (CBZ-CR) in the treatment of subjects with newly diagnosed epilepsy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2005
Typical duration for phase_3
223 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedMarch 17, 2015
March 1, 2015
2.7 years
September 9, 2005
March 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to withdrawal from study medication (starting at V1) as a measure of combined efficacy and safety
Visit 1 to End of Study (approximately 52 weeks)
Secondary Outcomes (11)
The time to withdrawal comparing Levetiracetam versus the older Antiepileptic Drugs based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release
Visit 1 to End of Study (approximately 52 weeks)
The retention rate after 6 months comparing Levetiracetam versus the older Antiepileptic Drugs
Visit 1 to Visit 4 (approximately 26 weeks)
The retention rate after 12 months comparing Levetiracetam versus the older Antiepileptic Drugs
Visit 1 to Visit 5 (approximately 52 weeks)
The retention rate after 6 months comparing Levetiracetam versus older Antiepileptic Drugs based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release
Visit 1 to Visit 4 (approximately 26 weeks)
The retention rate after 12 months comparing Levetiracetam versus older Antiepileptic Drugs based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release
Visit 1 to Visit 5 (approximately 52 weeks)
- +6 more secondary outcomes
Study Arms (2)
Levetiracetam
EXPERIMENTALDaily dose of 1000 to 3000 mg film-coated oral tablets, 250-500 mg twice daily.
Older Antepileptic Drugs
ACTIVE COMPARATOROlder AEDs consist of CBZ-CR 200 mg and 400 mg and VPA-ER 300 mg and 500 mg.
Interventions
Daily dose of 1000 to 3000 mg film-coated oral tablets, 250-500 mg twice daily.
Daily dose of 600-1600 mg CR oral tablets, 200 mg and 400 mg twice daily.
Daily dose of 1000-2000 mg ER oral tablets, 300 mg and 500 mg twice daily.
Eligibility Criteria
You may qualify if:
- Diagnosis of epilepsy (all types of seizures) was made during the past year
- Subjects must have had at least two unprovoked seizures in the past 2 years with at least one during the last 6 months
- Female subjects without childbearing potential are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method
You may not qualify if:
- Subjects previously allocated to a trial treatment (CBZ, VPA and LEV) used in this trial
- Participation in another clinical trial with an investigational drug or device within 12 weeks of the selection visit (V1), or at any time during this trial
- Pregnant or lactating women
- Presence of known pseudoseizures within the last year
- Uncountable seizures (clusters) or history of convulsive status epilepticus
- Any disorder or condition that may interfere with the absorption, distribution, metabolisation or excretion of drugs
- History of suicide attempt, current suicidal ideation, or other serious psychiatric disorders requiring or having required hospitalization or medication within the previous five years
- Presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors
- Presence of a terminal illness or any medical condition that might interfere with the subject's trial participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (229)
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Adelaide, Australia
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Bedford Park, Australia
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Brisbane, Australia
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Cairns, Australia
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Camperdown, Australia
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Chatswood, Australia
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Clayton, Australia
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Maroochydore, Australia
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Parkville, Australia
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Perth, Australia
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Randwick, Australia
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West Heidelberg, Australia
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Graz, Austria
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Innsbrick, Austria
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Klagenfurt, Austria
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Linz, Austria
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Steyr, Austria
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Vienna, Austria
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Bruges, Belgium
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Edegem, Belgium
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Ghent, Belgium
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Haine-Saint-Paul, Belgium
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Jette, Belgium
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Kortrijk, Belgium
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Leuven, Belgium
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Ostend, Belgium
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Ottignies, Belgium
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Plovdiv, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
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Litomyšl, Czechia
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Ostrava-Poruba, Czechia
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Zlín, Czechia
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Aalborg, Denmark
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Holbæk, Denmark
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Holstebro, Denmark
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Hus (Helsinki), Finland
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Kuopio, Finland
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Tampere, Finland
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Blaye, France
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Dijon, France
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Lille, France
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Nancy, France
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Rennes, France
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Saint-Brieuc, France
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Saint-Quentin, France
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Altenburg, Germany
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Celle, Germany
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Dillingen, Germany
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Erbach im Odenwald, Germany
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Halle, Germany
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Liegau-Augustusbad, Germany
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Mittweida, Germany
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Münster, Germany
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Neukirchen-Vluyn, Germany
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Oldenburg, Germany
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Quickborn, Germany
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Regenburg, Germany
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Schalmstadt-Treysa, Germany
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Aklion, Greece
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Vittoria, Italy
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Eindhoven, Netherlands
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Heerenvegen, Netherlands
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Nijmegen, Netherlands
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Tilburg, Netherlands
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Drammen, Norway
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Lillehammer, Norway
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Molde, Norway
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Nordbyhagen, Norway
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Tønsberg, Norway
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Bydgoszcz, Poland
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Częstochowa, Poland
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Poznan, Poland
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Warsaw, Poland
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Zgierz, Poland
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Bucharest, Romania
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Cluj-Napoca, Romania
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Craiova, Romania
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Krasnoyasrk, Russia
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Moscow, Russia
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Saint Petersburg, Russia
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Bratislava, Slovakia
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Dolný Kubín, Slovakia
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Dubnica nad Váhom, Slovakia
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Martin, Slovakia
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Žilina, Slovakia
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Badalona, Spain
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Barakaldo Vizcaya, Spain
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Barcelona, Spain
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Castellon, Spain
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Elda, Spain
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Girona, Spain
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Leganes (Madrid), Spain
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Madrid, Spain
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Móstoles, Spain
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Murcia, Spain
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Santa Cruz de Tenerife, Spain
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Seville, Spain
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Vigo, Spain
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Karlstad, Sweden
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Linköping, Sweden
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Motala, Sweden
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Stockholm, Sweden
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Varberg, Sweden
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Bern, Switzerland
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Biel, Switzerland
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Geneva, Switzerland
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Lausanne, Switzerland
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Sankt Gallen, Switzerland
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Zurich, Switzerland
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Adana, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Bursa, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Ashford, United Kingdom
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Bangor, United Kingdom
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Bristol, United Kingdom
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Dundee, United Kingdom
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Leeds, United Kingdom
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London, United Kingdom
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Plymouth, United Kingdom
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Southampton, United Kingdom
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Stoke-on-Trent, United Kingdom
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Sunderland, United Kingdom
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Swindon, United Kingdom
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Truro, United Kingdom
Related Publications (2)
Pohlmann-Eden B, Marson AG, Noack-Rink M, Ramirez F, Tofighy A, Werhahn KJ, Wild I, Trinka E. Comparative effectiveness of levetiracetam, valproate and carbamazepine among elderly patients with newly diagnosed epilepsy: subgroup analysis of the randomized, unblinded KOMET study. BMC Neurol. 2016 Aug 23;16(1):149. doi: 10.1186/s12883-016-0663-7.
PMID: 27552848DERIVEDTrinka E, Marson AG, Van Paesschen W, Kalviainen R, Marovac J, Duncan B, Buyle S, Hallstrom Y, Hon P, Muscas GC, Newton M, Meencke HJ, Smith PE, Pohlmann-Eden B; KOMET Study Group. KOMET: an unblinded, randomised, two parallel-group, stratified trial comparing the effectiveness of levetiracetam with controlled-release carbamazepine and extended-release sodium valproate as monotherapy in patients with newly diagnosed epilepsy. J Neurol Neurosurg Psychiatry. 2013 Oct;84(10):1138-47. doi: 10.1136/jnnp-2011-300376. Epub 2012 Aug 29.
PMID: 22933814DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
UCB Pharma
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 15, 2005
Study Start
February 1, 2005
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
March 17, 2015
Record last verified: 2015-03